Overview
- 19 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-12-07.
At a glance
Inspections
19
Form 483s
4
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 5 Dec 2022 – 7 Dec 2022 | Medical Devices & Rad Health | Clean | |
| 24 Jun 2019 – 27 Jun 2019 | Medical Devices & Rad Health | 483 | View 483 → |
| 12 Oct 2016 – 14 Oct 2016 | Medical Devices & Rad Health | Clean | |
| 4 Aug 2016 – 15 Aug 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 6 Jul 2015 – 7 Jul 2015 | Medical Devices & Rad Health | Clean | |
| 17 Oct 2012 | Not recorded | Clean | |
| 23 Nov 2011 | Not recorded | 483 | View 483 → |
| 21 Jan 2011 | Not recorded | Clean | |
| 3 Jun 2010 | Not recorded | Clean | |
| 30 Sep 2009 | Not recorded | 483 | On file |
| 25 Jun 2009 | Not recorded | Clean | |
| 12 Mar 2008 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Patrick B Cummings4 insp.
Joseph R Strelnik3 insp.
Calvin K Cook2 insp.
Suyang Qin1 insp.
Myra K Casey1 insp.
Juliane C Lessard1 insp.
Brittany M Lowe1 insp.
Corrine M Carter1 insp.
Debara R Reese1 insp.
Kennita Riddick1 insp.
Cynthia L Aycock1 insp.
Cynthia Li1 insp.
Charles M Spyr1 insp.
Larry K Austin1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 806.10(a)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 812.40 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Roche Diagnostics Corporation's 4 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat